BHB supplement for High Blood Pressure
(BHB Trial)
Recruiting in Palo Alto (17 mi)
Overseen byEléonor Riesco, PhD
Age: 18 - 65
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Université de Sherbrooke
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to determine the effect of acute consumption of a ketone monoester supplement in healthy male adults.
The main questions it aims to answer are:
* To determine if acute consumption of a ketone monoester supplement modulates diurnal (measured in lab) and nocturnal blood pressure (assessed by ambulatory blood pressure monitoring; ABPM) compared to a taste-matched placebo. The investigators hypothesize that a ketone monoester supplement will acutely decrease systolic and diastolic blood pressure compared to the placebo. The same results are expected for diurnal and nocturnal blood pressure.
* To determine if acute consumption of a ketone monoester supplement improves glucose control measured with continuous glucose monitoring (CGM) following a standardized meal consumed 90 minutes after ingestion of the ketone supplement. The investigators hypothesize that a ketone monoester supplement, consumed 90 minutes before a meal, will decrease the 2-hour postprandial glucose incremental area under the curve (iAUC) and peak glucose compared to a placebo.
* To assess IL-10's ability to inhibit proinflammatory cytokine production (TNF- α and IL-1β) in LPS-stimulated whole blood cultures following the ingestion of β-OHB and placebo. The investigators hypothesize that β-OHB will augment the ability of IL-10 to inhibit TNF-α and IL-1β production compared to placebo.
Using a double-blind placebo-controlled randomized crossover study design, 15 adults will participate in two experimental conditions. Participants will be recruited using a local recruitment database (Nabû), during presentations in community organizations, with posters at the University of Sherbrooke, and from word of mouth.
Following screening, eligible participants will be invited for one baseline and two experimental conditions at the Research Centre on Aging (CdRV). During the baseline visit, the following assessments and tests will be conducted:
* resting heart rate (HR) and blood pressure;
* anthropometry and body composition;
* medical history and questionnaires on physical activity levels, dietary habits and anxiety symptoms;
* explanation of the dietary and physical activity logs;
* installation of accelerometers to control physical activity levels and sedentary behaviors over 10 days and CGM to assess glucose control over the subsequent 10 consecutive days.
During the week following the baseline condition, participants will be invited to the laboratory for their first experimental condition (duration = 240 minutes). Participants will come to the lab in a fasted state (at least 12-hour overnight) to the lab at 8:00 am where following assessments and tests will be conducted:
* resting heart rate (HR) and blood pressure;
* ketone supplement or placebo consumption;
* blood samples and cold pressor test;
* standardized breakfast;
* galvanic skin response;
* visual analog scales assessing gastrointestinal discomfort, hunger and fullness;
* installation of ABPM and explanation of the dietary and physical activity logs.
Forty-eight hours later, participants will complete the same experimental condition with the alternate supplement (ketone or placebo) according to their randomization.
Eligibility Criteria
Inclusion Criteria
You are a healthy male adult.
You are between 20 and 45 years of age.
Exclusion Criteria
Changes in any type of medication in the last 6 months
Prior history of cardiovascular disease or stroke
Individuals following a ketogenic diet, low-calorie diet, periodic fasting regimen or consuming ketogenic supplements
+3 more
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BHB supplement conditionExperimental Treatment1 Intervention
Group II: Placebo solution conditionPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre de recherche sur le vieillissementSherbrooke, Canada
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Who Is Running the Clinical Trial?
Université de SherbrookeLead Sponsor
University of British ColumbiaCollaborator